CN106661111A - 抗体制剂 - Google Patents

抗体制剂 Download PDF

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Publication number
CN106661111A
CN106661111A CN201580037513.2A CN201580037513A CN106661111A CN 106661111 A CN106661111 A CN 106661111A CN 201580037513 A CN201580037513 A CN 201580037513A CN 106661111 A CN106661111 A CN 106661111A
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China
Prior art keywords
ser
pharmaceutical preparation
leu
gly
val
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Pending
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CN201580037513.2A
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English (en)
Chinese (zh)
Inventor
A.布莱克-哈斯金斯
T.马歇尔
K.奥贝里
M.D.珀金斯
G.H.克罗特斯
M.普里
D.M.邓利维
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GlaxoSmithKline Intellectual Property Development Ltd
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GlaxoSmithKline Intellectual Property Development Ltd
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Publication of CN106661111A publication Critical patent/CN106661111A/zh
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/04—Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Neurology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Rheumatology (AREA)
  • Inorganic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Pulmonology (AREA)
  • Obesity (AREA)
  • Pain & Pain Management (AREA)
CN201580037513.2A 2014-05-16 2015-05-15 抗体制剂 Pending CN106661111A (zh)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201461994427P 2014-05-16 2014-05-16
US61/994,427 2014-05-16
US201462093734P 2014-12-18 2014-12-18
US62/093,734 2014-12-18
US201462095181P 2014-12-22 2014-12-22
US62/095,181 2014-12-22
PCT/IB2015/053602 WO2015173782A1 (en) 2014-05-16 2015-05-15 Antibody formulation

Publications (1)

Publication Number Publication Date
CN106661111A true CN106661111A (zh) 2017-05-10

Family

ID=53200250

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201580037513.2A Pending CN106661111A (zh) 2014-05-16 2015-05-15 抗体制剂

Country Status (16)

Country Link
US (5) US10556009B2 (https=)
EP (3) EP3719038A1 (https=)
JP (2) JP6707528B2 (https=)
KR (2) KR102501602B1 (https=)
CN (1) CN106661111A (https=)
AU (1) AU2015260758B2 (https=)
BR (1) BR112016026811A2 (https=)
CA (1) CA2949212C (https=)
DK (1) DK3143047T3 (https=)
ES (1) ES2927990T3 (https=)
IL (1) IL248802B (https=)
MX (1) MX381232B (https=)
MY (1) MY185802A (https=)
SG (1) SG11201609622PA (https=)
TW (1) TWI694836B (https=)
WO (1) WO2015173782A1 (https=)

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WO2020108497A1 (zh) * 2018-11-29 2020-06-04 和铂医药（香港）有限公司 一种抗pd-l1抗体制剂
CN113546252A (zh) * 2020-04-24 2021-10-26 上海君实生物医药科技股份有限公司 抗pcsk9抗体的药物递送装置
WO2023226617A1 (zh) * 2022-05-23 2023-11-30 南京融捷康生物科技有限公司 一种稳定的抗体制剂
WO2024027793A1 (en) * 2022-08-05 2024-02-08 I-Mab Biopharma (Hangzhou) Co., Ltd. Bispecific antibodies targeting ifnar1 and blys
CN118255895A (zh) * 2024-04-30 2024-06-28 中国医学科学院皮肤病医院(中国医学科学院皮肤病研究所) 抗BAFF和hIL21双特异性抗体及其应用
RU2853138C2 (ru) * 2022-05-23 2025-12-22 Реджейнкор Биотех Ко., Лтд Стабильный состав на основе антитела (варианты), набор, содержащий его (варианты), применение стабильного состава (варианты), способ лечения с применением стабильного состава (варианты) и способ получения стабильного состава

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TWI694836B (zh) 2014-05-16 2020-06-01 英商葛蘭素史克智慧財產管理有限公司 抗體調配物
WO2016065181A1 (en) 2014-10-23 2016-04-28 Amgen Inc. Reducing viscosity of pharmaceutical formulations
US20190175683A1 (en) * 2016-08-05 2019-06-13 Csl Behring Gmbh Pharmaceutical formulations of c1 esterase inhibitor
IL317989A (en) 2016-08-17 2025-02-01 Compugen Ltd Anti-TIGIT antibodies, anti-PVRIG antibodies and combinations thereof
JP7377596B2 (ja) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
US10093731B2 (en) 2017-02-24 2018-10-09 Kindred Biosciences, Inc. Anti-IL31 antibodies for veterinary use
MX2019012255A (es) * 2017-04-11 2019-12-05 Kiniksa Pharmaceuticals Ltd Formulacion estable de anticuerpo contra el receptor de oncostatina m (osmr).
CN110769848A (zh) * 2017-05-16 2020-02-07 瑞士奥克特珐玛公司 C1-酯酶抑制剂制剂
WO2019201904A1 (en) * 2018-04-16 2019-10-24 Merck Patent Gmbh Viscosity reduction of highly concentrated protein formulations
AU2020251627A1 (en) * 2019-03-29 2021-11-11 Jiangsu Hengrui Medicine Co., Ltd. Pharmaceutical composition containing antibody against IL-5 and use thereof
EP4003417A2 (en) * 2019-07-29 2022-06-01 Compugen Ltd. Anti-pvrig antibodies formulations and uses thereof
KR20220093347A (ko) * 2019-11-06 2022-07-05 노파르티스 아게 쇼그렌 증후군의 치료
KR20230006824A (ko) 2020-04-24 2023-01-11 킹스칼리지런던 Ige 항체를 포함하는 조성물
GB202006093D0 (en) 2020-04-24 2020-06-10 King S College London Composition
US20230220092A1 (en) * 2020-06-12 2023-07-13 GlaxSmithKline Intellectual Property Management Limited Anti-Blys Antibody for Treating Proteinuric Kidney Disease
WO2022106460A2 (en) 2020-11-18 2022-05-27 Astrazeneca Ab Steroid sparing
US20240301031A1 (en) 2021-03-31 2024-09-12 Jiangsu Hengrui Pharmaceuticals Co., Ltd. Truncated taci polypeptide and fusion protein and use thereof
WO2022223028A1 (zh) * 2021-04-23 2022-10-27 上海君实生物医药科技股份有限公司 抗BLyS抗体、其药物组合物及其用途
BR112023024657A2 (pt) * 2021-06-17 2024-02-20 Glaxosmithkline Intellectual Property Ltd Anticorpos anti-baff para uso em um método de tratamento de covid longo e/ou sequelas agudas pós-infecção por sars-cov2 (pasc)
KR20240038773A (ko) 2021-07-27 2024-03-25 아스트라제네카 아베 루푸스의 치료
AU2024239150A1 (en) 2023-03-21 2025-10-02 Biograph 55, Inc. Cd19/cd38 multispecific antibodies

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020108497A1 (zh) * 2018-11-29 2020-06-04 和铂医药（香港）有限公司 一种抗pd-l1抗体制剂
CN113546252A (zh) * 2020-04-24 2021-10-26 上海君实生物医药科技股份有限公司 抗pcsk9抗体的药物递送装置
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